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Steps of Certification

Step 1: Request Application 
The first step in the process is to obtain an Application Package from the AOAC RI. This package contains information about the program, what types of data are required, application fees, and the agreements. 

Step 2: Submit Performance Data 
Manufacturers are required to collect and submit data to the AOAC RI that supports the product performance claims of the test kit. This data should follow the guideline of the Data Submission Requirement documents and be submitted in a method validation report format. In addition, the manufacturer must submit QA/QC information, package insert/user manuals, fee, and application. 

Step 3: Review of Submitted Data 
Usually two Expert Reviewers are recruited and one General Referee selected by the AOAC RI to review the performance data collected and submitted by the test kit manufacturer. The Expert Reviewers and the General Referee first evaluate the product descriptive inserts to determine the completeness of the inserts and to determine the exact performance claims made for the test kit. Then the Expert Reviewers and the General Referee evaluate the submitted the performance data to determine whether or not the data supports the product. 

Step 4: Development of Independent Testing Lab Protocols 
After the Expert Reviewers and General Referee have determined the adequacy of the product descriptive inserts and confirmed that the submitted data supports the product performance claims, then the Expert Reviewers and General Referee develop a testing protocol for the Independent Testing Laboratory selected by the AOAC RI to conduct additional performance testing of the test kit. 

Step 5: Independent Testing 
Test kits, samples and the testing protocol developed by the Expert Reviewers and the General Referee are forwarded to the Independent Testing Laboratory which then conducts additional performance testing of the test kit. 

Step 6: Review of Independent Testing Lab Data 
The data generated by the Independent Testing Lab is sent to the AOAC RI, and then distributed back to the Expert Reviewers and the General Referee. The Expert Reviewers and the General Referee then review the data generated by the Independent Testing Lab to determine whether or not this data corroborates with the data originally submitted by the manufacturer. 

Step 7: Recommendation 
If the Expert Reviewers and the General Referee determine that the independent testing lab data corroborates with the manufacturer generated data submitted with the application, and that the product descriptive inserts adequately describe the product performance, then a recommendation is made to grant Performance Tested Methods status to the test kit, and the kit manufacturer is licensed to use the certification mark for one year. 

APPROVAL

Publication
Successful test kit certifications will be announced in the AOAC magazine, Inside Laboratory Management, with selected portions of the performance data of the test kit may also be published. A more complete method validation report describing the method and the evaluation is published in the Journal of the AOAC INTERNATIONAL. 

Annual Renewal 
Performance Tested Methods status must be renewed on an annual basis. AOAC RI reviews the kit package insert/user manual to ensure the kit still conforms to the conditions of the Performance Tested Methods certification. The manufacturer must sign the renewal application certifying that no changes have been made to the test kit, the package insert, the manufacturing and quality assurance programs since originally receiving Performance Tested Methods status. This annual review ensures that no changes have occurred in the test kit that may adversely affect the performance of the test kit and ensures that the package inserts and user manual remain accurate. 

Changes in the Test Kit
It is the test kit manufacturer's contractual obligation to immediately notify the AOAC RI if and when any changes are made to: (1) the instructions for using the kit or (2) the kit's performance. Failure to promptly notify the AOAC RI of kit changes may result in cancellation of the Performance Tested Methods certificate. If changes are made in the test kit, the submission of new performance data similar to the original data package must be provided. When the AOAC RI receives notice of a kit change, the managing director, generally in consultation with appropriate experts, will determine if the changes are of sufficient magnitude to warrant a complete reevaluation of the kit. If so, the applicant of record must submit a complete application with the corresponding fee.

Complaints
The manufacturer must maintain a record of complaints and their resolution, which will be made available to the AOAC RI on request. Failure to adequately address user complaints will result in the AOAC RI initiating an inquiry and could lead to cancellation of the kit's Performance Tested Methods status.

 
 
 
 
 

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